Pilot Study for the Evaluation of Intravitreal Infliximab in the Treatment of Uveitic Macular Edema
This study has been withdrawn prior to enrollment.
(PI left institution (there are no data results for this study))
Sponsor:
Mount Sinai School of Medicine
Information provided by:
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00958906
First received: August 11, 2009
Last updated: June 21, 2011
Last verified: June 2011
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Purpose
The purpose of this study is to determine if intravitreal infliximab is a safe and effective treatment for macular edema secondary to uveitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Uveitic Macular Edema Intraocular Inflammation |
Drug: Infliximab (intravitreal, 2.0mg/0.05ml) |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Study for the Evaluation of Intravitreal Infliximab in the Treatment of Uveitic Macular Edema |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
MedlinePlus related topics:
Edema
Drug Information available for:
Infliximab
U.S. FDA Resources
Further study details as provided by Mount Sinai School of Medicine:
Primary Outcome Measures:
- Best-corrected visual acuity [ Time Frame: Three months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Macular thickness [ Time Frame: One, two, and three months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 10 |
| Study Start Date: | August 2009 |
| Study Completion Date: | October 2009 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Intravitreal infliximab |
Drug: Infliximab (intravitreal, 2.0mg/0.05ml)
One injection of intravitreal infliximab (2.0mg/0.05ml).
Other Name: Remicade™
|
Detailed Description:
Participants with uveitic macular edema will be treated with one injection of intravitreal infliximab (2.0mg/0.05ml) and followed for three months. Outcomes that be assessed include best-corrected visual acuity, macular thickness as measured by optical coherence tomography, and electroretinogram responses.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Participant must be 18 years of age or older.
- Participant must understand and sign the protocol's informed consent document.
Participants must have uveitic macular edema in one eye as defined by all of the following criteria:
- Presence of active intermediate uveitis or posterior uveitis.
- Macular edema defined as a central macular thickness of ≥ 250 μm on OCT.
- Uveitis must be noninfectious as determined by standard investigations used in the diagnostic investigation of uveitis.
- Participant must have visual acuity between 20/40 and hand motions in the study eye.
- Participant must have a steady fixation in the study eye and media clear enough for good quality imaging.
- Female participants of childbearing potential must not be pregnant or breast-feeding, must have a negative pregnancy test at screening and must practice an adequate method of birth control. Males able to father a child must agree to practice birth control. Acceptable methods of birth control include hormonal contraception (birth control pills, injected hormones or vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom and spermicide) or surgical sterilization (hysterectomy, tubal ligation or vasectomy in a partner). If a participant is of childbearing potential, she must be willing to undergo monthly urine pregnancy tests. Both males and females must agree to use adequate birth control for three months after the intravitreal infliximab injection.
Exclusion Criteria:
- Participant is in another investigational study and actively receiving study therapy.
- Participant is unable to comply with study procedures or follow-up visits.
- Participant has uveitic macular edema (as defined above) in both eyes.
- Participant has multiple sclerosis or symptoms suggestive of multiple sclerosis.
- Participant has evidence of ocular disease other than uveitis in either eye that may confound the outcome of the study (e.g., diabetic retinopathy, age-related macular degeneration, vitreomacular traction, moderate/severe myopia, etc.).
- Participant is expected to need ocular surgery in the study eye during the course of the study.
- Participant has undergone ocular surgery or an intravitreal/periocular steroid injection in the study eye within the past 3 months.
- Participant has had a YAG laser capsulotomy or intravitreal anti-VEGF treatment in the study eye within the past 6 weeks.
- Participant has had a pars plana vitrectomy in the study eye.
- Participant is on ocular or systemic medications known to be toxic to the lens, retina, or optic nerve.
- Participant with a history of ocular herpes simplex virus infection in the study eye.
- A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control).
- There are no criteria for inclusion/exclusion for the fellow eye. Only one eye can have macular edema in order for the potential participant to be considered for enrollment.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958906
Locations
| United States, New York | |
| Department of Ophthalmology, Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
| Principal Investigator: | Farzin Forooghian, MD | Mount Sinai School of Medicine |
More Information
Publications:
| Responsible Party: | Farzin Forooghian, MD, Assistant Professor, Department of Ophthalmology, Mount Sinai School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00958906 History of Changes |
| Other Study ID Numbers: | GCO # 09-0611 |
| Study First Received: | August 11, 2009 |
| Last Updated: | June 21, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Mount Sinai School of Medicine:
|
Infliximab Uveitis Macular Edema Intraocular Inflammation |
Additional relevant MeSH terms:
|
Edema Inflammation Macular Edema Chorioretinitis Uveitis Signs and Symptoms Pathologic Processes Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Retinitis |
Choroiditis Choroid Diseases Uveal Diseases Uveitis, Posterior Panuveitis Infliximab Dermatologic Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents Antirheumatic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 22, 2013